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Comparing doravirine and dolutegravir for treating HIV-1 in new patients

Phase III, Open-label, Randomized, Multicenter Trial EvaLuating the Non-inferiority of DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

Phase 3 Interventional ANRS, Emerging Infectious Diseases · NCT06203132

This study is testing if a new HIV treatment called doravirine works just as well as the standard treatment dolutegravir for people who are starting their first HIV therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment610 (estimated)
Ages18 Years and up
SexAll
SponsorANRS, Emerging Infectious Diseases Government
Locations19 sites (Nova Iguaçu, Rio de Janeiro and 18 other locations)
Trial IDNCT06203132 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the effectiveness of doravirine combined with tenofovir and lamivudine against dolutegravir with either tenofovir and lamivudine or emtricitabine in treatment-naïve individuals living with HIV-1. The study is multicenter, open-label, and randomized, aiming to determine if doravirine is non-inferior to dolutegravir in achieving viral suppression. A total of 610 participants will be enrolled and monitored for 96 weeks, with the primary endpoint focusing on the proportion of patients achieving an HIV-1 RNA level of less than 50 copies/mL at Week 48.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are HIV-1 positive, treatment-naïve, and have a viral load of at least 1,000 copies/mL.

Not a fit: Patients with ongoing tuberculosis or those who have previously received antiretroviral therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment option for patients newly diagnosed with HIV-1.

How similar studies have performed: Previous studies have shown promising results with similar antiretroviral regimens, indicating that this approach is supported by existing evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Be at least 18 years of age on the day of signing the informed consent.
* Be HIV-1 positive as determined according to national testing strategies
* Have a plasma HIV-1 RNA ≥1000 copies/mL within 30 days prior to the randomization,
* Have HIV treatment indication based on physician assessment according to local treatment guidelines
* Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents
* For women or transgender men of childbearing potential i.e. of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods
* Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial.

Non-inclusion Criteria:

* Has ongoing (pulmonary or extra-pulmonary) tuberculosis
* Has any other history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
* Is infected with HIV-2 or co-infected with HIV-1 and HIV-2
* Has received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP).
* Has received oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the past three months or has had no negative HIV-1 serology performed
* Has documented or known resistance or possible resistance to study drugs (in France and where national guidelines recommend screening for primary resistance before starting first-line ART) as defined by the ANRS MIE AC43 Resistance group
* Has the following laboratory values at screening visit, within 30 days prior to the randomization:

  * AST (SGOT) and ALT (SGPT) \>4.0 x upper limit of normal
  * Estimated glomerular filtration rate at time of screening \<60 mL/min/1.73m², based on the CKD-EPI equation
* Has participated in a study with an investigational compound/device within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
* Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
* Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol.
* Has significant hypersensitivity or other contraindication to any of the components of the study drugs.
* Is pregnant, breastfeeding, or expecting to conceive at any time during the study.
* Has any condition which might, in the investigator's opinion, compromise the safety of treatment and/or patient's adherence to study procedure.
* Is a person under guardianship or deprived of freedom by a judicial or administrative decision

Where this trial is running

Nova Iguaçu, Rio de Janeiro and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV-1-infectionHIV-1ART-naïvedoravirinedolutegravirnon-inferiority
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.